Phase 2 Study of Weekly Tirzepatide Injections to Assess Metabolic Effects in Adults with Type 1 Diabetes

What this Trial Is About

Researchers are evaluating the effects of Tirzepatide TZP, a medication that targets specific hormones involved in metabolism, in adults with type 1 diabetes T1D. This phase 2 clinical trial aims to understand how TZP influences insulin sensitivity, hormone levels after meals, during low blood sugar episodes, and overnight, building on previous research findings. The study focuses on the acute metabolic effects of TZP over a short treatment period to explore potential benefits beyond weight loss. Participants will receive either a weekly injection of Tirzepatide 2.5 mg or a placebo for 6 weeks. The study is double-blinded and placebo-controlled, meaning neither participants nor researchers know who receives the active drug or placebo during the trial. Treatment is delivered by subcutaneous injection administered by study nurses. The trial uses advanced methods like hyperinsulinemic-euglycemic and hypoglycemic clamps to assess metabolic changes in various physiological states. During the study, participants will undergo detailed assessments including insulin sensitivity, hormone secretion, energy expenditure, blood sugar levels, and gastric emptying before and after the treatment period. These evaluations involve clinical tests and monitoring of daily insulin doses and blood glucose variability. Safety and response to treatment will be closely observed, with the total study duration lasting 6 weeks of treatment plus screening and follow-up periods as scheduled.

Acute Metabolic Effects of Tirzepatide in Type 1 Diabetes